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Patient reported outcomes: Effectiveness of hormonal treatments for acne. Jerry Tan MD, FRCP 1 Karen Y. Fung PhD 2 1 University of Western Ontario and 2 University of Windsor, Windsor, Ont. . Declarations. Conflict of interest: Study sponsored by Berlex, Roche, Stiefel, Dermik

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patient reported outcomes effectiveness of hormonal treatments for acne

Patient reported outcomes:Effectiveness of hormonal treatments for acne

Jerry Tan MD, FRCP1

Karen Y. Fung PhD2

1University of Western Ontario and

2University of Windsor, Windsor, Ont.

declarations
Declarations
  • Conflict of interest:
    • Study sponsored by Berlex, Roche, Stiefel, Dermik
  • Acknowledgements:
    • Canadian Acne Study Group: Richard Thomas, Yves Poulin, Aditya Gupta, Sheetal Sapra, Wayne Gulliver, Charles Lynde, Rolf Sebaldt
background
Background

3 hormonal preparations currently indicated in Canada for treatment of acne:

  • Tri-Cyclen® (Ortho-McNeil)
  • Alesse® (Wyeth)
  • Diane-35® (Berlex)

There are no clinical trials comparing their relative effectiveness

objective
Objective
  • To determine the relative effectiveness of these 3 hormonal agents in treatment of acne
  • To evaluate the effect of hormonal treatment on acne-specific quality of life
methods i
Methods I

Data from Canadian acne epidemiological survey (observational study )

  • New acne patients
  • Referred to 7 participating dermatologists
  • Clinical evaluations
    • IGA, Leeds score, Acne-QoL™
  • Treatment: usual clinical practice
methods ii
Methods II

Relative effectiveness evaluated in 2 ways:

  • Retrospectively - patient responses to questions on effectiveness of previous hormonal therapy
  • Prospectively - evaluation of outcomes after at least 4 months of treatment
retrospective phase inclusion
Retrospectivephase - inclusion
  • Females
  • Prior use of only one of the hormonal treatments for acne
  • No prior use of oral isotretinoin
retrospective phase results
Retrospective phase - results
  • N= 91
  • No difference between groups:
    • Mean age
    • Duration of acne
    • Duration of treatment
effectiveness ratings
Effectiveness ratings
  • 1. Patient responses converted numerically with higher numbers = greater effectiveness
  • Proportion of patients rating treatment as moderate-extremely effective
prospective phase inclusion criteria
Prospective phase Inclusion criteria
  • females;
  • no history of oral isotretinoin use
  • only one hormonal treatment prescribed at visit 1 or 2
  • no other hormone treatments within 2 months of visit 1
  • if hormone started at visit 1, this was not changed at visit 2
  • Visit 3 (6 month) data available
  • Minimum compliance of 75%
acne qol
Acne-QoL™

(with permission from Merck & Co.)

prospective phase results
Prospective phase - results
  • Prospective evaluation performed only for the Diane-35® cohort (N=17)
    • Insufficient sample sizes for Tricyclen® and Alesse® cohorts (N=1 each)
results acne qol
Results: Acne-QoL™
  • total score improvement of 19%

(P = 0.017)

  • improvement in all 4 domains:
    • Self-perception
    • Symptoms (P < 0.05)
    • Emotional
    • Socialization (P = 0.24)
results prospective analysis
Results: Prospective analysis
  • Patient rating treatment as moderate-extremely effective:
    • 12/17 (71%)
  • Objective improvement (Leeds, IGA)
    • 12/17 (71%)
summary
Summary

Patients previously treated with one of the 3 hormonal preparations, ranked Diane-35 as the most effective.

Patients treated with Diane-35 demonstrated improvement in acne symptoms and acne-related emotional and self-perception domains

study limitations
Study Limitations
  • Retrospective study
    • Recollection bias: comparator cohorts and sample size should minimize confounding
  • Prospective analysis
    • lack of a cohort comparator group
    • completion of Acne-QoL before medical encounter should reduce pre-bias of responses
    • results represent usual clinical practice of combining topical treatments with Diane-35